Kornimate/medical-research-clean huggingface dataset:
preventing cognitive decline with metformin

Conditions: Cognitive Decline

Summary: a randomised control study of metformin in people with mild cognitive impairment and without diabetes mellitus to determine effects on cognitive decline and neuroimaging over 3 years.

a randomised placebo-control study of metformin in people with mild cognitive impairment and without diabetes mellitus to determine effects on cognitive decline, neuroimaging and biomarkers over 3 years.

Eligibility criteria:
inclusion criteria: * overweight or obese (body mass index \>25.0 kg/m2, waist: women\>80 cm, men\>94cm; * mild cognitive impairment (mild neurocognitive disorder), based on dsm-5 criteria; * fasting blood glucose \<7.0 mmol/l and hba1c \<6.5%; * able to undertake neurocognitive testing in english. * not participating in another trial of drugs or lifestyle modification to reduce cognitive decline. exclusion criteria: * life-threatening illnesses to preclude participation in a 3-year study; * contraindications to the use of metformin (severe heart failure or egfr \<40).

Keywords: cognitive decline dementia cerebrovascular disease insulin resistance neurodegeneration inflammation diabetes
exercise training in asthma

Conditions: Asthma

Summary: the aim of the study is to compare two methods of exercise training: alternate load versus constant load realized at moderate or high intensities, in order to define the interests and the limits of each one of these two methods. the finality is to make possible to the expert to choose what exercise training induces the best results quickly and to make its choice according to the therapeutic objectives which it lays down.we also evaluate the effects of these exercises training on the vagal response and the bronchial tone of the asthmatics. from a clinical point of view, a close attention will be paid to the effects of these exercises training on the control of asthma and the quality of life of the subjects


Eligibility criteria:
inclusion criteria: * 18 to 45 years old * mild to moderate persistent asthma (gina classification) * stabilized asthma * physical activity level between 5 and 11 (baecke and coll, 1982) * no contra-indication for physical training exclusion criteria: * cardiovascular pathology * metabolic pathology * traumatic pathology * bmi≥30 * tobacco * diabetes

Keywords: asthma asthmatic subjects exercise training constant load alternate load
feasibility study of the uriprene stent following uncomplicated ureteroscopy

Conditions: Unilateral Ureteral Stone; Renal Stone Fragments ≤ 2mm

Summary: a prospective, single-center, single-arm, trial to demonstrate safety and device performance of the adva-tec uriprene™ degradable temporary ureteral stent. this is a first-in-man clinical study in a small human population.

primary objective: to assess the safety and feasibility of the uriprene® stent by assessing the time to complete degradation or the passage of stent fragments from the bladder by radiological assessment. subject population: patients with clinical symptoms consistent with unilateral ureteral or renal stone fragments ≤ 2mm, post-uncomplicated ureteroscopy (uurs).

Eligibility criteria:
inclusion criteria: 1. patients who are \> 18, \< 80 years of age; inclusive of males and females. 2. patients with unilateral ureteral or renal stone fragments \< 2mm, post-uncomplicated ureteroscopy (uurs). 3. patients with a height and body size able to accommodate a 20, 22, 24, 26, 28, or 30 mm long ureteral stent, as judged by the investigator. 4. patients with the ability to understand the requirements of the study, who have provided written informed consent, and who have agreed to return for the required follow-up assessments. exclusion criteria: 1. patients with a known contraindication for treatment with the uriprene® stent. 2. patients with a history of an anatomical abnormality of the urinary tract. 3. patients with a known upper or lower urinary tract infection at the time of stent insertion. 4. patients with known renal insufficiency or chronic impairment. 5. any condition, in the opinion of the investigator, in whom patients would not be eligible for treatment with the uriprene® stent. 6. pregnant or lactating women, or women of childbearing potential who do not employ a reliable method of contraception as judged by the investigator. 7. patients who consume more than 14 drinks of alcohol per week (as this may affect degradation of the stent). 8. presence of ureteral blockage or stricture 9. after failed guide wire placement or failed ureteroscopic access 10. impacted ureteral stones still in place 11. patients predisposed to urinary stasis e.g. neurogenic bladder, bladder outlet obstruction, known pregnancy 12. patients with a solitary kidney 13. presence of ureteral fistula 14. presence of ureteral tumor 15. presence of extrinsic compression of the ureter 16. urinary tract infection 17. staghorn calculi

Keywords: renal stone ureteroscopy ureteral stent post-uncomplicated ureteroscopy uurs
automated insulin delivery for inpatients with dysglycemia (aiding) feasibility

Conditions: Diabetes Mellitus

Summary: this single-arm stepwise feasibility study will test initial deployment of hybrid closed-loop (hcl) automated insulin delivery (aid) using the omnipod 5/horizon hcl system with remote monitoring and device operation capabilities to hospitalized patients admitted to the general medical/surgical floor with diabetes (type 1 or type 2) requiring insulin therapy.

this single-arm stepwise feasibility study will test initial deployment of hybrid closed-loop (hcl) automated insulin delivery (aid) using the omnipod 5/horizon hcl system with remote monitoring and device operation capabilities to hospitalized patients admitted to the general medical/surgical floor with diabetes (type 1 or type 2) requiring insulin therapy. all enrolled participants will be placed on hcl insulin therapy for 10 days or until hospital discharge (if less than 10 days) to determine functional operability of the system and its effect on glycemic control in the hospital setting. this study will generate preliminary data to inform the design of a large multi-institution randomized controlled trial to assess superiority of hcl compared to standard inpatient insulin therapy.

Eligibility criteria:
inclusion criteria: * patients ≥18 years of age with insulin-treated t1 or type 2 diabetes mellitus (t2dm) admitted to general (non-intensive care) medical-surgical hospital service requiring inpatient insulin therapy. exclusion criteria: * patients admitted the icu or anticipated to require icu transfer * anticipated length of hospital stay \<48 hours. * evidence of hyperglycemic crises (diabetic ketoacidosis or hyperosmolar hyperglycemic state) at enrollment * severely impaired renal function (egfr \< 30 ml/min/1.73m2) or clinically significant liver failure * severe anemia with hemoglobin \<7 g/dl * evidence of hemodynamic instability * hypoxia (spo2 \<95% on supplemental oxygen) * pre-admission or inpatient total daily insulin dose \>100 units * mental condition rendering the participant unable to consent or answer questionnaires * pregnant or breast feeding at time of enrollment * unable or unwilling to use rapid-acting insulin analogs (humalog, admelog, novolog or apidra) during the study * use of hydroxyurea or high-dose ascorbic acid (\>1g/day) * coronavirus disease 2019 (covid-19) infection or person under investigation (pui) on isolation precautions

Keywords: automated insulin delivery hybrid closed-loop system inpatient insulin therapy
anesthetic requirement and stress hormone response during surgery in spinal cord-injured patients

Conditions: Complete Spinal Cord Injury; Surgery

Summary: spinal cord injury (sci) reduces anesthetic requirements and stress hormonal responses. anesthetic requirements and stress hormone response are compared in sci patients undergoing anesthesia with sevoflurane supplemented with clinically equivalent doses of either n2o or remifentanil.

nitrous oxide (n2o) is often used for anesthetic adjuvant, but may be associated with side effects and toxicities. remifentanil shares characteristics with n2o, including anesthetic-reducing and antinociceptive effects and a rapid recovery. anesthetic requirements and stress hormone response in sci patients undergoing anesthesia with sevoflurane supplemented with clinically equivalent doses of either n2o or remifentanil. forty-five sci patients scheduled to undergo pressor sore surgery below the level of the injury are randomly allocated to receive either sevoflurane alone (control, n=15), or combined with 67% n2o (n=15) or target-controlled infusions of 1.37 ng/ml remifentanil (n=15). sevoflurane concentration is titrated to maintain a bispectral index (bis) value of 40-50. measurements include end-tidal sevoflurane concentrations, mean arterial blood pressure (map), heart rate (hr), and plasma catecholamine and cortisol concentrations.

Eligibility criteria:
inclusion criteria: * asa physical status ii, with chronic, clinically complete cord injuries scheduled for a surgery for pressure sore below the level of the neurologic lesion under general anesthesia. exclusion criteria: * cardiovascular, pulmonary, or metabolic diseases. patients who took medications that would influence autonomic or cardiovascular responses to the surgery

Keywords: spinal cord injury stress hormone surgery bispectral index value volatile anesthetic
wild blueberries and cardiovascular health in middle-aged/older men and postmenopausal women

Conditions: Hypertension; Aging; Endothelial Dysfunction; Men

Summary: cardiovascular disease (cvd) is the leading cause of morbidity and mortality worldwide. aging is the primary risk factor for cvd, in large part due to adverse modifications to the arteries. these modifications include vascular endothelial dysfunction and arterial stiffness. vascular endothelial dysfunction is an initiating step in atherosclerosis, and is primarily caused by reduced nitric oxide (no) bioavailability secondary to excessive superoxide-driven oxidative stress and inflammation. endothelial dysfunction leads to arterial stiffness and the development of hypertension (htn) which further increases cvd. greater than 2/3 of the us population has elevated blood pressure or stage 1-htn. as such, interventions that improve vascular endothelial dysfunction by increasing no bioavailability and mitigating excessive oxidative stress and inflammation are needed. blueberries are rich in bioactive compounds including flavonoids, phenolic acids, and pterostilbene. these compounds and their metabolites have been shown to attenuate oxidative stress and inflammation. the primary goal of this study is to assess the efficacy of blueberries to improve reduce blood pressure and improve vascular endothelial dysfunction and arterial stiffness in middle-aged/older men with elevated blood pressure or stage 1-htn.


Eligibility criteria:
inclusion criteria: * men and postmenopausal women * aged 45-70 years * elevated blood pressure or stage 1-hypertension * ability to provide informed consent exclusion criteria: * have had a menstrual cycle within the past year * blood pressure \< 120 (systolic bp) or ≥ 140/90 mm hg * reactive hyperemia index \> 3.00% * taking \> 1 antihypertensive medication, taking 1 antihypertensive medication more than 1 time per day, and/or taking the antihypertensive medication for \< 3 months * diagnosed cancer, cardiovascular disease, diabetes, or gastrointestinal, kidney, liver, lung, and/or pancreatic disease * triglycerides \> 350 mg/dl, low-density lipoprotein cholesterol (ldl-c) ≥ 190 mg/dl, hemoglobin a1c ≥ 6.5%, and/or taking a lipid-lowering or glucose-lowering medication * testosterone or estrogen replacement therapy use 6 months prior to study start * weight change ≥ 3 kg in the past 3 months, actively trying to lose weight, or unwilling to remain weight stable throughout the study * current smokers or history of smoking in the past 12 months * binge and/or heavy drinker (\>3 drinks on any given occasion and/or \>7 drinks/week for women, and \>4 drinks on any given occasion and/or \>14 drinks/week for men) * body mass index \ 40 kg/m2 * antibiotic therapy within past two months * allergies or contraindication to study treatments or procedures

Keywords: cardiovascular disease blueberries hypertension vascular dysfunction atherosclerosis aging
effect of stellate nerve block in dysphagia

Conditions: Dysphagia

Summary: this is a randomized controlled study, including dysphagic patients with bulbar palsy after ischemic stroke who were received in the department of rehabilitation medicine in china. both groups were provided with comprehensive rehabilitation including routine rehabilitation and swallowing function training. besides, the observation group additionally underwent the stellate ganglion block (sgb). at admission and after 20-day treatment,yale pharyngeal residue severity rating scale, video fluoroscopic swallowing study (vfss), functional oral intake scale, and penetration-aspiration scale (pas) were used to assess swallowing function.

dysphagia is a frequent and potentially serious complication of stroke. this is a randomized controlled study, including dysphagic patients with bulbar palsy after ischemic stroke who were received in the department of rehabilitation medicine in china. both groups were provided with comprehensive rehabilitation including routine rehabilitation and swallowing function training. besides, the observation group additionally underwent the stellate ganglion block (sgb). at admission and after 20-day treatment,yale pharyngeal residue severity rating scale, video fluoroscopic swallowing study (vfss), functional oral intake scale, and penetration-aspiration scale (pas) were used to assess swallowing function.

Eligibility criteria:
inclusion criteria: * diagnosed with ischemic stroke according to the diagnostic criteria, with the stroke occurring in the medulla oblongata and diagnosed as bulbar palsy. * dysphagia. * age \>18 years. * first-time stroke. * steady vital signs, * transferred or admitted to the department of rehabilitation medicine within 15d after onset. exclusion criteria: * allergy to lidocaine injection or vitamin b12 injection; * severe cognitive impairment; * coagulation disorders; * severe dysfunction of organs including heart, lungs, kidney, liver, etc.; * complicated with other neurological diseases; * dysphagia caused by other diseases or reasons.
serum inflammatory marker in patients with diagnosis of nontuberculous mycobacterial pulmonary infection

Conditions: Nontuberculous Mycobacterial Pulmonary Infection

Summary: this study is for those who had nontuberculous mycobacterial pulmonary infection with higher a serum inflammatory marker than those who had colonization.

nontuberculous mycobacteria (ntm), not like mycobacterium tuberculosis, is ubiquitous in environment including soil and water. therefore, ntm pulmonary infection is not diagnosed only by microbiology of respiratory specimen but also clinical and radiographical findings.(1) due to airway ntm colonization is not uncommon in sputum, diagnosis of pulmonary ntm infection is a big challenge in clinical practice. especially ntm burden is increasing in recent literature.(2,3) besides, the short-term mortality is reported higher in patients with ntm infection in medical icu by shu et al.(4) early diagnosis and then treatment of ntm infection become important though ntm infection is considered as indolent process before.(1) inflammatory marker in the patients with ntm being isolated from respiratory specimens is an indicator for differentiating true infection from colonization.(5,6) those inflammatory factors might include blood white count, c-reactive protein, cytokines, procalcitonin , trigger receptor expressed on myeloid cell-1 (trem-1) and toll-like receptor-2. we therefore conduct this prospective study for analyzing

Eligibility criteria:
inclusion criteria: * more than 18 years * study group : satisfied the criteria for ntm pulmonary disease according to the ats diagnosis guidelines. * control groups: they had positive sputum culture for ntm but not fulfilled the diagnosis criteria exclusion criteria: * those with bleeding tendency * no inform consent * female with pregnancy

Keywords: make sure the difference of the serum inflammatory marker between the two groups
the effect of temporal muscle suspension of temporal hollowing

Conditions: Temporal Wasting

Summary: the primary objective is to identify which patients undergoing a traditional pterional approach with 2 different surgical techniques for tms (temporal muscle suspension) will develop th (temporal hollowing. pre and post-operative ct scans will be reviewed and analysis with previously proven metrics will be performed.

the pterional approach is an indicated neurosurgical approach commonly used for anterior circular aneurysms, suprasellar lesions, and medial sphenoid wing tumors (1,2). a curvilinear incision from the midline widows peak and extending laterally to 1 cm anterior to the tragus of the ear, terminating within a skin crease, with preservation of the superficial temporal artery if possible. the temporalis fascia is encountered and divided. either the entire temporalis muscle can be elevated or a cuff of temporalis muscle can be left on the cranium to facilitate closure and suspend the temporalis muscle. subperiosteal dissection of the muscle is performed and the craniotomies are then accomplished. reconstruction of the pterional approach can be accomplished with bony fixation of the bone flap. however, the tms can be performed by: 1. resuspension of the temporalis muscle to the cuff of muscle left on the temporal crest or 2. suturing the temporalis muscle directly to one of the bone plates that is used to for fixation. the purpose of this prospective study is see if traditional techniques to the closure and temporal muscle suspension (tms) after the pterional approach will show any differences in post-operative temporal hollowing (th).

Eligibility criteria:
inclusion criteria: * this study will include all patients over the age of 18 years who qualify for a pterional approach for their neurosurgical pathology. exclusion criteria: * excluded patients will be protected populations, such as inmates or children. patients will not be excluded on the basis of pregnancy.

Keywords: pterional incision temporal hollowing
evaluation of the impact of nurse-led telephone on treatment compliance

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the study will take place over a period of 27 months. the recruitment phase will last approximately 24 months and each patient will participate for approximately 3 months. at the inclusion visit (d0), the investigator will ask the patient whether he would like to participate in the study and will obtain his written consent. patients agreeing to participate will be randomised (3:1 ratio) and included in one of the following 2 groups: group without 'remote additional personalised nurse-led follow-up: patients will receive the healthcare given routinely by their medical team (100 patients). group with 'remote additional personalised nurse-led follow-up: patients will receive telephone calls from a nurse in addition to the healthcare given routinely by their medical team (300 patients). all the patients will be seen according to normal practice by the study medical team. patients in the group with 'remote additional personalised nurse-led follow-up will be contacted 8 times during the study (at d1, d7, d14, d21, d28, d44, d59 and d89). the nurse will make sure that the treatment takes place in good conditions; she cannot intervene in the medical care of the patient, nor give answer to the questions relative to the disease or to the treatment of the patient. the medical team remains the privileged contact of the patient.

purpose: study design:

Eligibility criteria:
inclusion criteria: male or female patient older than 18 years. adult patient diagnosed with stage iiib/iv nsclc locally advanced or metastatic, with activating mutation(s) of egfr and who is egfr-tki naïve. patient for whom a decision of treatment with afatinib monotherapy has been taken in the frame of its marketing authorization. out-patient. patient having given written consent for participation in the study. patient who is able to participate in the investigator's opinion. patient affiliated with the french social security. exclusion criteria: patients participating in an interventional clinical study. patients for whom a participation in an interventional clinical study is foreseen within 3 months following the study inclusion. patients participating in a therapeutic education program.
a study to determine the satisfaction with actonel in postmenopausal women with osteoporosis

Conditions: Osteoporosis, Postmenopausal

Summary: the study in the labeled and real conditions of prescription of actonel will investigate the satisfaction of patients with its new formulation: 35 mg once a week. the study will also measure response rates in ctx (the c-telopeptide of type i collagen) at baseline and after 12 weeks of treatment with risedronate 35 mg once a week.


Eligibility criteria:
inclusion criteria: * postmenopausal outpatients women \> 55 and \< 70 years who have a clinical presentation appropriate for treatment of established osteoporosis based on the investigator's clinical judgment (a t-score for bmd (dexa) of lumbar spine or femoral neck less than or equal to - 2.5 from an assessment performed at screening or within 12 months prior to the screening visit or evidence of previous vertebral fracture). exclusion criteria: * history of cancer: basal cell or squamous cell carcinoma-documented 6-month remission. * diagnosis of hypocalcemia, hyperparathyroidism, hyperthyroidism. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
safety, pharmacokinetics, and preliminary efficacy study of cdz173 in patients with primary sjögren's syndrome

Conditions: Primary Sjögren's Syndrome

Summary: this study is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary therapeutic efficacy of oral administrations of cdz173 in patients with primary sjögren's syndrome.

this study is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary therapeutic efficacy of oral administrations of cdz173, a selective pi3k delta inhibitor, for 12 weeks, in patients with primary sjögren's syndrome. data from this study will provide the basis for further development of the compound for the treatment of primary sjögren's syndrome.

Eligibility criteria:
inclusion criteria: * diagnosis of primary sjögren's syndrome (pss) * essdai score ≥ 6 at screening visit exclusion criteria: * secondary sjögren's syndrome other protocol-defined inclusion/exclusion criteria may apply.
impact of dairy products on postprandial inflammation

Conditions: Inflammation; Obesity; Nutritional Intervention

Summary: the study will quantitatively evaluate the systemic, postprandial inflammatory and metabolic response to the ingestion of three different meals in obese subjects. the administered meals will differ in the proportion of dairy products. postprandial response will be monitored during 6 hours after meal consumption.


Eligibility criteria:
inclusion criteria: * male * bmi ≥ 20 kg/m2 * age 25-55 y * informed consent exclusion criteria: * physiological or psychological diseases * allergies to food or intolerance to high-fat meal * vegetarians * chronic intake of drugs * smokers * diabetes mellitus type i and ii * debilitating kidney diseases * debilitating liver diseases * clinically established coronary heart diseases * ingestion of vitamins or dietary supplements during the course of the study